De Novo · Granted
GrantedQuantra Hemostasis Analyzer, QPlus Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemosonics, LLC · QFR Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
Granted on Mar 12, 2019 as a new device type through De Novo after a 344-day review. 4 later devices descend from it.
- Decided
- Mar 12, 2019
- Review
- 344 days
- Class
- Class II
- Product code
- QFR
- Recalls
- None
4 later devices descend from it, 2 citing it directly.
- This deviceDEN180017 Quantra Hemostasis Analyzer, QPlus CartridgeHemosonics, LLC · 2019
- Descendant · cites it directly · 2 of its ownK223433 Quantra QPlus SystemHemosonics, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK230461 Quantra Hemostasis AnalyzerHemosonics, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK232215 Quantra Hemostasis AnalyzerHemosonics, LLC · 2023
- Descendant · cites it directly · 0 of its ownK201513 Quantra QPlus SystemHemosonics, LLC · 2020
Most influential descendants
Showing 4 of 4 · See all- K223433Quantra QPlus SystemHemosonics, LLC · 2022 · cites it directly2descendants
- K230461Quantra Hemostasis AnalyzerHemosonics, LLC · 2023 · 2 generations on1descendant
- K232215Quantra Hemostasis AnalyzerHemosonics, LLC · 2023 · 3 generations on0descendants
- K201513Quantra QPlus SystemHemosonics, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180017 | Quantra Hemostasis Analyzer, QPlus Cartridge | Hemosonics, LLC | 2019 | — |
| +1 | K223433 | Quantra QPlus System | Hemosonics, LLC | 2022 | — |
| +2 | K230461 | Quantra Hemostasis Analyzer | Hemosonics, LLC | 2023 | — |
| +3 | K232215 | Quantra Hemostasis Analyzer | Hemosonics, LLC | 2023 | — |
| +1 | K201513 | Quantra QPlus System | Hemosonics, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QFR device
- #1 K251404 Quantra QStat Cartridgescore 10.8 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K223433 (Hemosonics, LLC, 2022) has gone furthest, with 2 descendants of its own.
How does its category compare?
All QFR devicesQFR Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QFR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QFR
Too few QFR 510(k)s in any year since 2007 to give a median.
Recalls per year · QFR
No recall names QFR since 2007.
Adverse event reports per year · QFR
No MAUDE report names QFR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Quantra QPlus System is composed of the Quantra Hemostasis Analyzer, QPlus Cartridge, and Quantra Quality Controls Level 1 and 2. The Quantra QPlus System is intended for in vitro diagnostic use. The Quantra Hemostasis Analyzer uses Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry, an ultrasound-based technology, to measure the shear modulus of whole blood during coagulation. The QPlus Cartridge is a multi-channel cartridge that…
Read the full statement (220 words)
The Quantra QPlus System is composed of the Quantra Hemostasis Analyzer, QPlus Cartridge, and Quantra Quality Controls Level 1 and 2. The Quantra QPlus System is intended for in vitro diagnostic use.
The Quantra Hemostasis Analyzer uses Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry, an ultrasound-based technology, to measure the shear modulus of whole blood during coagulation. The QPlus Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation state of a 3.2% citrated venous whole blood sample. The QPlus Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes tests with a heparin neutralizer.
The system is intended to be used by trained professionals at the point-of-care and in clinical laboratories to evaluate the viscoelastic properties of whole blood by means of the following functional parameters: Clot Time (CT), Clot Time with Heparinase (CTH), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS) and Clot Time Ratio (CTR).
The Quantra QPlus System is indicated for the evaluation of blood coagulation in perioperative patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions in cardiovascular or major orthopedic surgeries before, during, and following the procedure.
Results obtained with the Quantra QPlus System should not be the sole basis for patient diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180017 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180017: Quantra Hemostasis Analyzer, QPlus Cartridge.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180017
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026